FDA.reportPublic FDA data

Barco

Primary DI
05415334050020
Brand
Barco
Company
Barco NV
Model
MDSC-8532
Catalog number
K9353018
Device description
MDSC-8527 NXF M2
Published
2025-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415334050020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334050020054153340500205415334050020

GMDN Terms#

Term, Definition table
TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 866-302-7939service.medical.usa@barco.com

Regulatory Flags#

DUNS number
371618773
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334053168BarcoMDSC-8532K93531112026-06-02
05415334053335BarcoMDSC-8532K93531212026-06-02
05415334056411BarcoMDSC-8527K93530121X2026-06-02
05415334056428BarcoMDSC-8532K93530131X2026-06-02
05415334056435BarcoMDSC-8527K93530181X2026-06-02
05415334056442BarcoMDSC-8532K93530191X2026-06-02
05415334061750BarcoMDNC-6121K9300360C2X2026-06-02
05415334057265Nio Color 8MPMDNC-8132K9300830B2X2026-05-07
05415334062412Nexxis ORNexxis systemK96104262026-04-28
05415334036277Nexxis ORNexxis systemK96104202021-06-28
05415334057258Eonis 32”MDRC-8132K9350830B2X2026-04-13
05415334000148Nio 2MPE 2620 S2016-06-30
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334000155Barco Mammo TomosynthesisMDMG-52212016-06-30
05415334000162Coronis 3MP LEDMDCG-32212016-06-30
05415334000247Coronis Fusion 4MP LEDMDCC-4330K9301625A2016-06-30
05415334000261Coronis Fusion 6MP LEDMDCC-6430K9301635A2016-06-30
05415334000339Nio 3MP LEDMDNG-3220K9301860A2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415334053168BarcoBarco NVKQM2026-06-02
05415334053335BarcoBarco NVKQM2026-06-02
05415334056411BarcoBarco NVKQM2026-06-02
05415334056428BarcoBarco NVKQM2026-06-02
05415334056435BarcoBarco NVKQM2026-06-02
05415334056442BarcoBarco NVKQM2026-06-02
04995047074946CuratOREIZO CORPORATIONKQM2026-05-29
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeMicro-Tech (Nanjing) Co., Ltd.KQM2026-05-15
03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
00810000890675ArthrexFORESEESON CUSTOM DISPLAYS, INC.KQM2026-05-08
03700712434472Maquet OrchideMAQUET SASKQM2026-05-06
03700712434489Maquet OrchideMAQUET SASKQM2026-05-06
04548736183407SONYSONY CORPORATIONKQM2026-04-30
04548736183414SONYSONY CORPORATIONKQM2026-04-30
00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
04548736155978SONYSONY CORPORATIONKQM2025-11-04
04548736155985SONYSONY CORPORATIONKQM2025-11-04
04548736169968SONYSONY CORPORATIONKQM2025-11-04
04548736169951SONYSONY CORPORATIONKQM2025-10-06
04548736155091SONYSONY CORPORATIONKQM2025-09-30
04548736155107SONYSONY CORPORATIONKQM2025-09-30
04548736170735SONYSONY CORPORATIONKQM2025-09-30
04548736170759SONYSONY CORPORATIONKQM2025-09-30
00848657077729AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-09-25
10618125114662SironaTIDI PRODUCTS, LLCKQM2025-07-10
04548736170681SONYSONY CORPORATIONKQM2025-06-24
04548736170704SONYSONY CORPORATIONKQM2025-06-24
00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09
10884389024997MEDLINEMEDLINE INDUSTRIES, INC.KQM2024-09-20
00848657076968ENDOPRO-CAM Master SeriesNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2024-07-15